Orthopedic plates for use in clavicle repair and methods for their use

ABSTRACT

The present invention relates to a series of orthopedic plates for use in repair of a bone. The plate has a Y-shaped profile or an X-shaped profile which includes an elongate central trunk with a complex contour and either one or two terminal pairs of arms that have a first arm and a second arm that form differing angles and lengths relative to the trunk portion of the plate. The arms include locking screw holes where the screws converge toward each other to provide for multiplanar fixation but which do not impinge.

CROSS-REFERENCE

This application is continuation application of pending U.S. patentapplication Ser. No. 13/348,888, filed on Jan. 12, 2012 for ORTHOPEDICPLATES FOR USE IN CLAVICLE REPAIR AND METHODS FOR THEIR USE which is adivisional of U.S. Pat. No. 8,118,846, issued on Feb. 21, 2012 forORTHOPEDIC PLATES FOR USE IN CLAVICLE REPAIR AND METHODS FOR THEIR USEwhich is a CIP of U.S. Pat. No. 7,771,457, issued on Aug. 10, 2010 forORTHOPEDIC PLATE FOR USE IN SMALL BONE REPAIR which claimed priority toU.S. Provisional Application Ser. No. 60/648,364 filed on Jan. 28, 2005for ORTHOPEDIC PLATE FOR USE IN SMALL BONE REPAIR.

FIELD OF THE INVENTION

The present invention relates to orthopedic plates in particular forsurgical repairs or reconstruction of a clavicle and to a method for theuse of these plates.

BACKGROUND OF THE INVENTION

The field of orthopedic medicine has grown tremendously in the pastfifty years as surgical techniques, implants and instrumentation havedeveloped and been improved. The small bones are frequently subject tothe need for re-constructive surgery for example, as a result of trauma,to counteract the effects of aging or to repair congenital deformitiesand trauma and spinal areas. While there is a wide variety in the exactshape and mass of all bones, these variations become more problematic inproviding orthopedic implants for small bone applications since there isless room on and about the bone for the surgeon to place and fix theconstruct. These bones are finer and have less surface area forplacement of an implant, have less mass for the placement of screws andare often surrounded by less muscle and by more vulnerable tendons,blood vessels and nerves. As a result, individual variations become moreproblematic for orthopedic plates of stock design. Consequently,surgeons have tended to rely on the use of screws and wires forreconstruction or have had to resort to operating room contouringprocedures which can weaken the plates and/or distort the screw holeswithin the plates. This is a particular problem in instances in whicheither variable locking mechanisms are used, or in which locking screwsare used with the plates. None-the-less, locking screws often are usedto advantage as they provide more secure placement of the screws in thebone, cause better compression through a fractures, and are less likelyto harm the bone or back out of the plate.

One problem that needs to be avoided in the delicate environment of thesmall bone area is the interference of screws, with other screws, andwith the function of ligaments and tendons. While it may be desirable todesign an orthopedic plate so that securing screws converge in order tocause compression or increase the pullout strength, it is difficult whena screw impinges on or conflicts with the desired placement of anotherscrew. Some surgeons prefer bicortical fixation in which a screw issized so that the distil end is secured in cortical bone giving thescrew better purchase, however, other surgeons may prefer to avoidplacing a screw so that it projects beyond the outer surface of theanchoring bone. These factors are complicated by the relative lack ofsoft tissue and the presence of ligaments and tendons in the small boneareas. Consequently, the less forgiving biological environment in whichthe small bone surgeon works requires greater procedural precision andcalls for specialized implants and tools.

The present invention is designed to meet the specific needs of thesmall bone surgeon to facilitate effective and repeatable procedureswhich provide for ease of use and a range of function for this specificarea of specialization. The present invention is specifically intendedto provide for the treatment of fracture repair following trauma in anotherwise healthy individual where plates are used to maintain theintegrity of the bones while they heal, although it is certainlypossible that they may also be used for other surgeries such asreconstruction to correct congenital or age related deformation orissues that relate to prior mal-union of the bone following a priorinjury.

The plates of the present invention are designed specifically for therepair or reconstruction of a clavicle, which is commonly called a“collarbone”. The collarbones, like the cheekbones, are covered only byskin, and thus have a high correlation to the appearance of theindividuals and serve in many cultures as a marker of beauty. Thesebones further serve to protect the brachial plexus and the medial nerveand blood vessels that are immediately internal to them. They also serveas a strut and the only skeletal connection between the arms and thetorso, and they play a very sophisticated role in the functioning of theshoulder girdle, torso, scapular and arm kinesiology. The effect ofmisalignment and mal-union of clavicle fractures are only recently beingexamined from the viewpoint of the strength and stamina of the patientas it was previously viewed radiographically and thereforeunderestimated.

It has been reported that as many as 5% of all fractures seen in theadmissions department of an emergency room are clavicle fractures, whichoccur most commonly between the proximal ⅔ and the distal ⅓ of the bone.The more common fracture (approximately 80% of clavicle fractures)occurs in the middle third of the clavicle with an upward displacementof the proximal fragment of the bone by the sternocleidomastoid muscle.The weight of the shoulder muscles and of the adductor muscles of thearm may add to the fragment displacement, causing the shoulder to droop.This type of fracture often occurs as a result of a fall on anoutstretched hand or of a direct blow to the clavicle. The second mostcommon fracture (which may account for 10-15% of clavicle fractures)occurs in the distal ⅓ of the clavicle. The causes of the fractures aresimilar to those for the mid-shaft fractures, but also commonly includeblows to the shoulder region, such as occur in automobile collisions andparticularly physical sports such as hockey, lacrosse and football.Medial fractures are often associated with very severe trauma thatincludes injury to the vital organs and other indications ofco-morbidity.

It is often difficult to reduce and subsequently to maintain thereduction of clavicle fractures without surgical intervention, althoughboth union and healing proceeds rapidly, usually with the result of aprominent callus, and in some cases of mal-union, with the possibilityof medial cord nerve symptoms. In the past, non-surgical treatment hasoften involved immobilization of the associated limb, such as in afigure-of-eight bandage or a simple sling. In a study published in theJournal of Bone and Joint Surgery, 2006 (88:35-40), by McKee et al,Deficits Following Non-operative Treatment of Displaced Mid-shaftClavicle Fractures, the authors in particular note that that there was asubstantial loss of strength and endurance in clavicle fractures treatedwith a traditional sling approach, indicating substantial residualdisability despite apparently adequate range of motion. This and otherstudies have led to increased concern about providing wider range ofsurgical options for internal stabilization of the clavicle. However,the problem remains that the shape and size of clavicles vary greatlyand their visibility leaves little room for plates that do not generallyaccommodate this variation gracefully.

The present invention provides answers to the prior art issues byproviding a variety of plates with varying footprints that share anelongate central trunk with a medial line (which is intended in thisinstance to include a curving line) that divides the plate in halflaterally. The plate further has at least one pair of terminalasymmetrical arms that extend from the trunk at differing anglesrelative to the medial line and have differing lengths. The plates alsohave varying profiles (or contouring) in the z direction but again sharea transverse curve along the medial line about the side which faces thebone. The plates also all exhibit bilateral asymmetry (meaning that theleft half of the plate is not exactly the same as the right half ofplate taken from the medial line) and they all achieve bi-planar screwfixation (meaning that the screws do not lie in a single plane). Inaddition, while the plates are pre-contoured, the plates are designed tofacilitate three dimensional contouring (at least in the terminal arms)to accommodate individual variation in bone shape. The plates areconfigured to bend laterally, longitudinally, and to wrap or spiralabout the longitudinal axis or medial line so that they can be molded toan optimal shape for small bone procedures. The plates are designed toprovide optimal stabilization of fractures and osteotomies by providingmulti-planar fixation that allows for better pull-out and limited axialloading to the bone. The plates are further designed to acceleratefusion success by reducing or eliminating torsional or twisting stressesto the bone segments during the healing process. In addition, whendesired, the plates can be shaped so as to apply a compressive, or evena tensile, force, for example, along the longitudinal axis of a bone.

These plates are provided in a number of variations in a surgical tray,which include for example various lengths of the central trunk portion,which is provided with a line of screw holes centered along the medialline. Further the number of screw holes in the trunk can vary, and thetype of holes can vary to include translation slots, compression slots,and locking and non-locking screw holes. Thus, the tray selection allowsthe surgeon to select his plate during surgery after opening the woundarea and considering the plating needs. In addition, the tray includesplates of differing types for differing placement on the clavicles. In afirst embodiment of the clavicle plate of the present invention, a plateis provided for placement on the superior aspect of a clavicle, and in asecond embodiment, a plate is provided for placement on theanterior/inferior aspect of a clavicle, and in a third embodiment, aplate is provided for placement on the lateral aspect of a clavicle.

All of the plates have an elongate central trunk portion including oneor more screw holes which are optionally separated by a waist shapedlinking portion along a longitudinal axis or the medial line anddepending on the embodiment, the plate has one pair or two pairs of armswhich are preferably terminal to the central trunk, and which includescrew holes (i.e. one per arm) placed at an equal distance from thelongitudinal axis but which diverge asymmetrically from the longitudinalaxis to avoid conflicts in the screw placement of the paired arm,specifically, so that the screws of a set of arms avoid impinging oneach other and further to provide multiplanar fixation at the plateterminus. The plate is curved about the inferior surface, (i.e. thesurface which faces toward and which may, but does not have to fullycontact the bone), with a curvature corresponding generally to thecurvature of a bony surface. In most of the embodiments of the platethis contouring is the result of a blending of one or more series ofradiuses so that the plate may comprise a portion of a cylinder, orportions of a cylinders, or in the event that the medial line alsodefines a longitudinal curve in the z axis, a portion of a torroid. Thepair of arms continue this curvature to spiral or wrap around the bonelike a small portion of a double helix (i.e. extending through an arc ofless than about 50°). The screw holes within the arms are placed so thatthe angle of the longitudinal axis of the screws converge in thedirection of the distil end of the screw. The screw holes are placedwith the longitudinal axis perpendicular to a tangent to the top surfaceof the arm with the effect that the longitudinal axes of the screwsconverge in the direction of the distil end. The convergence of thescrew holes increases the pull-out strength of the screws.

Further the screw holes are rounded and the corresponding mating headsof the screws are rounded and have a low profile so that the screws canbe seated with their longitudinal axes at a variety of angles.Preferably, there is at least 20° of conical rotation, and morepreferably 25°, and most preferably 30° of conical rotation of the screwaxis in relation to the longitudinal axis of the screw hole (i.e. thelongitudinal axis of the screw can be rotated through a conical shapeabout the axis of the screw hole where the apex of the cone describes anangle of 30°). Alternatively and in many cases, preferably, the screwholes can include internal threads which mate with external threads onthe head of the screws to cause locking of the screws relative to theplate.

While the screws are at convergent angles, the screws typically do notin fact impinge on each other, or conflict in their placement since eachof the arms of the plate in a pair form a different angle to the centraltrunk so that the longitudinal axis of the screws are offset from eachother along the length of the plate. The radiused configuration of theplate is designed to increase operating room efficiency by facilitatingcommonly desirable shapes while maintaining the required strength and bypermitting bending without deforming the screw holes. This results inmaking customization in anticipation or during surgery easier.

The surgical tray of the present invention further includes a variety ofscrews. The screws useful with the plate of the present invention areself-starting, self-tapping screws including the option of partial orfull cannulation. The screws include a unique cutting end havingmultiple flutes, and preferably 2 or 3 flutes about a conical recess.The screws further include a partial taper of the inner diameter in theproximal end over the first several thread turns, for example over 2-8,and preferably over 3-5 turns in order to increase the fatigue life ofthe screw as well as providing potential physiological advantages inuse. The screws further include a torque driving recess that may be ahexagon, a torx shape, or a modification of a torx shape, i.e. amultilobe shape having from 3 to 12 lobes, and preferably having 4 to 8rounded recesses or lobes. The recess can be of a constant size in thedirection of the longitudinal axis, or can taper inward along thelongitudinal axis of the screw toward the bottom of the recess. Thescrews have a low profile, head which is rounded at the junction of thehead and the shaft, and also rounded from the maximum diameter towardthe top surface or the proximal end relative to the insertion tip, whichincludes the torque driving recess. This rounded low profile head keepsthe screw from having any sharp projecting edges which could provide anirritation to the tissue in the vicinity of the plate and further seatsin the plate so that no more than 10% by volume of the screw headprojects from the plate.

The instruments for use with the system are well-balanced andergonomically designed with sufficiently long handles to place thesurgeon's hands outside of the line of radiation and designed to reducefatigue in the operating room.

Depending on the intended placement of the plate, the central trunk, andthe plate itself includes a general topography (i.e. the contour in thez direction) designed to maximize the fit on a variety of shapes andsizes of clavicle while enabling, but reducing the need forindividualized contouring. This topography includes a c-shape lateralcurve in the superior and 4-hole anterior plates, a fishtail (i.e.having a broad curve in the direction of the bone-facing surface of theplate terminating in a short up-turned curve at the end of the plate)shape in the longer anterior plates. The lateral plate has an S-curve ofthe medial line in the direction of the width of the plate. The platesystem of the present invention is thus designed to fit a range of needsof the surgeon operating on the clavicles to allow him or her to perfecta variety of techniques using a set of instruments and a customizableplate and screw construct.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a first embodiment of an orthopedic plate inaccordance with the invention;

FIG. 2 is a cross-section of the plate of FIG. 1 taken along line 2-2;

FIG. 3 is a cross-section of the plate of FIG. 1 taken along line 3-3;

FIG. 4 is a cross-section of the plate of FIG. 1 taken along line 4-4;

FIG. 5 is a cross section of the plate of FIG. 1 taken along line 5-5;

FIG. 6 is a perspective view of a screw used with the present system;

FIG. 7 is a perspective view of a locking screw used with the presentinvention;

FIG. 8 is a top view of a first version of a second embodiment of theplate in accordance with the invention;

FIG. 9 is a cross section of the plate of FIG. 8 taken along line 9-9;

FIG. 10 is a mirror version of the plate shown in FIG. 8;

FIG. 11 is a cross section of the plate of FIG. 10 taken along line10-10;

FIG. 12 is an end perspective of a left version of a third embodiment ofa plate in accordance with the invention for placement on the anterioraspect of a clavicle;

FIG. 13 is a top view of the plate of FIG. 12;

FIG. 14 is a right end view of the plate of FIG. 12;

FIG. 15 is a right side view of the plate of FIG. 12;

FIG. 16 is a cross section of the plate of FIG. 12 taken across thewidth of the plate;

FIG. 17 is view of the plate of FIG. 12 placed on a clavicle;

FIG. 18 is an end perspective of a left version of a fourth embodimentof a plate in accordance with the invention for placement on theanterior aspect of a clavicle;

FIG. 19 is a top view of the plate of FIG. 18;

FIG. 20 is a right end view of the plate of FIG. 18;

FIG. 21 is a right side view of the plate of FIG. 18;

FIG. 22 is a cross section of the plate of FIG. 18 taken along line22-22;

FIG. 23 is view of the plate of FIG. 18 placed on a clavicle;

FIG. 24 is a top view of a left version of a fifth embodiment of a platein accordance with the invention for placement on the anterior aspect ofa clavicle;

FIG. 25 is an end perspective of the plate of FIG. 24;

FIG. 26 is a right end view of the plate of FIG. 24;

FIG. 27 is a right side view of the plate of FIG. 24;

FIG. 28 is a cross section of the plate of FIG. 24 taken along line28-28;

FIG. 29 is view of the plate of FIG. 24 placed on a clavicle;

FIG. 30 is an end perspective of a left version of a sixth embodiment ofa plate in accordance with the invention for placement on the superioraspect of a clavicle;

FIG. 31 is a top view of the plate of FIG. 30;

FIG. 32 is a right end view of the plate of FIG. 30;

FIG. 33 is a right side view of the plate of FIG. 31;

FIG. 34 is a cross section of the plate of FIG. 30 taken along line34-34;

FIG. 35 is view of the plate of FIG. 30 placed on a clavicle;

FIG. 36 is an end perspective of a left version of a seventh embodimentof a plate in accordance with the invention for placement on thesuperior aspect of a clavicle;

FIG. 37 is a top view of the plate of FIG. 36;

FIG. 38 is a right end view of the plate of FIG. 36;

FIG. 39 is a right side view of the plate of FIG. 36;

FIG. 40 is a cross section of the plate of FIG. 36 taken along line40-40;

FIG. 41 is view of the plate of FIG. 36 placed on a clavicle;

FIG. 42 is an end perspective of a left version of an eighth embodimentof a plate in accordance with the invention for placement on the lateralaspect of a clavicle;

FIG. 43 is a top view of the plate of FIG. 42;

FIG. 44 right end view of the plate of FIG. 42;

FIG. 45 is a right side view of the plate of FIG. 42;

FIG. 46 is an right end view of the plate of FIG. 42; and

FIG. 47 is a view of the plate of FIG. 42 placed on a clavicle.

DETAILED DESCRIPTION OF THE INVENTION

The plate 10 of the present invention is shown having a bilaterallyasymmetric shape with either one or two pairs of legs extending from acentral trunk portion 12 defining the longitudinal axis of the plate. Asshown the trunk portion 12 includes two screw holes or slots 14 alongthe longitudinal axis. However, as can be seen from FIGS. 12 through 18the plate can be presented in a version which has a plurality of screwholes, for example up to 8 or more. The number of screw holes in thetrunk portion 12 will depend on the length of the plate, and may rangefrom 0 to 8, and more preferably from 2 to 4. In one embodiment theseholes are compression holes or translation slots. The compression holes14 are preferably slotted or elongated and optionally may have a largerradius area 11 on each of the screw holes facing in the same direction,and a smaller radius area 13 in order to induce a compression toward thesmaller radius end. The holes may also or alternatively have a shallowshoulder or lip 18 which descends toward the inferior surface of theplate to allow the plate to be set initially and subsequently to beslide into a different position as the screws are tightened down. Thisallows compression to be applied across the middle of the trunk section.The plates include a visual indicator of the direction of thecompression, such as an arrow 17. Further, the screw holes can includeannular rings of increased thickness in the vertical direction aboutthrough holes 14.

The through holes 14 in the trunk portion 12 have a longitudinal axisthat is perpendicular to plane tangent to the top radius of the plate.The area linking the screw holes has a decreased width so as to define awaist area 26 that will bend laterally (or “curve”) relative to thelongitudinal axis and which will bend longitudinally to form a curvedarea in and out of the plane of the plate. This thinner area alsofacilitates twisting of the plate so as to allow the plate to spiral, orwrap around it longitudinal axis. The increased annular area around thethrough bores resists deformation when a bending device is used to applya force to the plate through the screw holes.

The plate 10 also includes at least one set of arms 20. As viewed inFIG. 1, these sets of arms can be viewed as a set of a short 22 and along arm 23. Each of the arms in a set includes screw holes 24 which areplaced at a radially equal distance but which diverging asymmetricallyfrom the longitudinal axis of the plate 10. More specifically, each setof arms includes one arm that defines a smaller angle of divergence afrom the longitudinal axis of the trunk portion than the angle ofdivergence of the other arm R. For example, the first angle shown inFIG. 1 at a may be from about 5° to about to 25°, and more preferablyfrom about 10° to about to 20° and most preferably from about 12° toabout to 16°, while the second angle shown at β from about 10° to aboutto 35° , and more preferably from about 15° to about to 30° and mostpreferably from about 22° to about to 26° with a preferred difference inthe angles beings from about 2° to about to 20°, and more preferablyfrom about 4° to about to 16° and most preferably from about 8° to aboutto 12°.

In addition to the angled arms of this asymmetrical shape facilitating avariety of useful positions in the small bone area, the plate of thepresent invention is sized to fit the needs of the small bonespecialist. For small bone usage, the total length of the plate alongits longitudinal axis is from about 25 mm to about 80 mm, depending onthe number of screw holes in the trunk portion. The total width is fromabout 12 mm to about 18 mm, with an inferior radius of curvature ofabout 8 mm to about 12 mm and a concentric radius on the superior side.Typically, the waist area measures from about 7.5 mm to about 10 mm fromthe center of the larger, i.e. about 3.8 mm, radiused portion of theholes. The trunk portion has a width of about 7 mm to about 9 mm wide atthe wider parts and about 3 mm to about 5 mm wide at the narrower waistportion. The longer arm has a length along the longitudinal axis of theplate from the center of the screw hole to the center of the plate for atwo-hole trunk of from about 12 mm to about 16 mm, with a width of about3 mm to about 5 mm. The shorter arm has a comparable length of fromabout 7 mm to about 15 mm with a narrowed width of about 2.5 to about 5mm. In a further embodiment the plate could be modified for use in thelong bones with a length of up to about 400 mm with a width of up toabout 50 mm, and proportional sizes for the arms and thickness.

On the inferior side, or the side that would be facing (whichcontemplates opposing or touching or partially touching) the bonesurface in use, the arms continue the radius of curvature of the trunkportion. The superior or top side of the plate has a similar radius ofcurvature as the top surface of the plate has an outline thatcorresponds with the shape of the bottom of the plate (excluding theoptional thickened annular area surrounding the screw holes which wouldact to shield these holes against deformation during bending.) The screwholes also include a rounded concavity to mate with the rounded shape ofthe head of the screw to allow of variable axis positioning. The screwholes 24 are placed with the longitudinal axis perpendicular a tangentto the top surface of the arm with the effect that the longitudinal axesof the screws converge in the direction of the distil end. Thisincreases the pull-out strength of the plate/screw construct. Since thearms are asymmetrical relative to each other, and in particular sincethey diverge from the longitudinal axis of the trunk portion atdiffering angles, conflicts in the positions of paired screws is avoidedso that the screws of a set of arms typically do not impinge on eachother. This is even more important in instances where the plate is bentaround the longitudinal axis so as to wrap around the longitudinal axisof the bone.

The arms 20 also each include a screw hole 24 which, like the trunkportion 12 has a linking portion 26 that joins the screw hole to thetrunk portion. Again this design facilitates the desired bending whileresisting deformation of the screw holes 24 when they are used with thebending instrument to contour the plate. The angle of the arms 20 ofeach one of a pair of arms (both top and bottom and right and leftpairs) varies so as to create a bilateral asymmetry, meaning that theplate is not symmetrical with respect to a plane that passes through thelongitudinal axis in the vertical direction from the superior (the topside relative to the bone) to the inferior side (the side facing thebone), the “first plane”.

The screws holes of the trunk portion can include means to induce acompressive force in one direction, such as a ramped area on each screwhole. These ramped areas would be ramped on the same side of the holeslooking down from the top of the plate. Typically the first screwimplanted stabilizes and the second screw is used to achievecompression. Further the length of each of the arms of a pair will varyso that the radial length of the center of the screw hole to theintersection with the longitudinal axis will be the same. As shown inFIGS. 3-5, the plate includes a radial curve about the longitudinalaxis. The radius is typically about 10 mm with a transverse dimensionfrom the edge of one arm to the edge of the other arm of a pair beingabout 15 or 16 mm for typical small bone usage, and the screw borehaving a longitudinal axis of about 24° to a plane passing through thelongitudinal axis of the plate. The bores are typically about 3.75 mmfor a 3.5 mm diameter screw for small bones excluding the smallest ofapplications which would include phalanges. Again, for the smallestapplication as well as long bone embodiments the screws andcorresponding screw holes could be sized to range from a 1.5 mm diameterscrew up to a 7.5 mm diameter screw. In a further embodiment, the borecould be threaded.

FIG. 6 shows a screw 81 which could be used with the plate system of thepresent invention. The distil end of the screw can include a cutting tipwhich is self-starting and self-tapping or a rounded blunt tip. Thisaspect is defined by a conical recess and a plurality of flutes. Thesescrews 81 can optionally include partial or full cannulation. The headof the screw 82 is spherical and includes a torque driving recess, suchas a modified multilobe shape. The screw has a cancelleous thread 83with a constant major diameter and a minor diameter that tapersproximally in order to increase fatigue life of the screw and to improvecompression and compensate for bone resorption. FIG. 7 shows a lockingscrew 86 which could be used with the present invention. The screwincludes the same features as the screw in FIG. 6, except that the screwfurther includes external threads 88 on the screw head.

FIGS. 8 through 11 show a second embodiment of a plate in accordancewith the present invention in which the plate shown in FIG. 10 is amirror image of the plate shown in FIG. 8. In this embodiment, the plate71, 71′ has a Y-shape with an elongate and cylindrical central trunkhaving a single pair of arms 72, 72′ extending as previously describedfrom the a trunk portion 73, 73′. The trunk portion optionally has oneor more compression slots 74,74′.

FIGS. 12 through 17 show an embodiment of the present invention forplacement on an anterior aspect of a left clavicle with the version forthe right clavicle being a mirror image. This embodiment of the plate210 has a profile having a central trunk 212 with two sets of terminalarms 220 similar to the plates shown in FIGS. 1-5 except that the shortarms extend away from the same side of the trunk relative to the medialline. Thus, the plate forms an X with two short arms 213 on the sameside and two longs arms 214 on the same side and the elongate centraltrunk 212 bridging the span between each terminal set of arms. Thecentral trunk includes a slight longitudinal curve, and the bottom 227of the plate has a radial curve as can be seen in the end view of FIG.14, and in the cross-section shown in FIG. 16. Thus, the plate forms asegment of a torroid. The trunk includes two translation slots 230,which are obround and in the middle of the plate and which are used forinitial fixation and which subsequently allow for translation of theplate relative to that fixation. The plate further includes two screwholes 232 which are shown as locking holes having internal threads.These holes further include keyways 233 for the mating portion of adrill guide in order to set the pilot hole for a locking screw receivedin these holes.

The plate 210 has a two pairs of arms 220 that extend as previouslydescribed. Specifically, for each pair of arms, each of the first 213and second arm 214 include a screw hole 235 which defines an axis of thescrew (perpendicular to a tangent at the diameter of the screw hole) andthe arms have a longitudinal axis which is a line intersecting the screwaxis and the longitudinal axis of the central trunk. The arms spiral orwrap around in the same direction that the central trunk does. The screwholes 235 are preferably threaded locking holes, which also includekeyways for a drill guide that sets the angle for the locking screw. Foreach arm, the longitudinal axis defines an angle relative to thelongitudinal axis of the central trunk, and the angle is different forone arm than for the other arm in a terminal pair as is shown for theembodiment shown in FIG. 1. The plate demonstrates a mirror symmetryabout the transverse plane since the two short arms have a correspondingangle, length and shape and the two long arms have a correspondingangle, length and shape.

As has been previously described, the pair of arms include an inferiorcurve in the same direction as the radial curve in the central trunkportion. The difference in the length and angles of the arms allows formultiplanar fixation and convergence of the screws (which are lockingscrews) while avoiding impingement of the screws with each other. Thus,the plate is designed to fit the lateral ⅔ of the clavicle and the armsare designed wrap around the shaft of the bone. The plate is shown witha central trunk that includes two obround slots in the central trunk andtwo locking screw holes that include internal threads and keyways for adrill guide to set the angles for the screws. The plate also includestwo terminal sets of arms each having a short arm and a long arm withthe short arms on the same side for ease of insertion through theincision. The plate can have one or no slots and from 1 to 8 screwholes. FIG. 17 illustrates the placement of the plate on theanterior/inferior aspect in the mid-shaft portion of a clavicle.

FIGS. 18-29 show two slightly different embodiments of the plate of thepresent invention which vary according to the length of the elongatecentral trunk and accordingly, to the number of screw holes in thissection of the plate. However, in both versions, the plate 310, 310′ hasa y-shaped footprint which comprises an elongate central trunk 312, 312′having a medial line and along the medial line, through holes, (whichcan either be slots 316, 316′ such as compression slots or translationslots) and/or screw holes 317, 317′ (which can either be smooth forvariable locking or threaded for locking holes). In these embodiments,the holes of the central body are aligned with their centers along astraight medial line (or in this instance a plane), which divides theplates in two lateral halves. The area between the through holes curvesinward toward the medial line to allow the plate to be further contouredwithout deforming the holes.

One end of the central trunk includes a single pair of arms 320, 320′with a longer arm extending at a first angle from the medial line of theplate and having a shorter length than the second arm which extends fromthe plate at a second angle and has a longer length. The arms include arounded portion 324, 324′ that defines a portion of a circle and has alinking area that has a smaller width than the diameter of the circle.Each rounded portion includes a screw hole 326, 326′ may advantageouslyinclude internal threads 328, 328′ and keyway grooves 329, 329′ for adrill guide. These embodiments of the plates are provided in a firstversion having five locking holes 317, in the central trunk and threeobround translation slots 316. The translation slots 316 may includecontouring with in the lateral edges of the slot that are convex toreceive the rear shoulder or rounded portion of the screw in order tocause the screw to seat in the plate perpendicularly to the medial line.The plate is provided in a right and a left version and the left versionis illustrated in the figures. In this version, the plate is curvedalong the medial line transverse to the medial line as can be seen inFIGS. 20 and 22. The plate also includes a larger contouring which islike the shape of a fishtail in that it bows gently from the end withthe pair of arms in a first direction for approximately the first ¾ to9/10 of the length of the plate, and then curves more sharply in theopposite direction along the z axis.

In the longer version of this plate 310′, the plate includes fourobround translation slots 316′ which are in the center between threelocking screw holes 317′ at the end with the arm 320′ and four lockingscrew holes 317′ at the other end of the central trunk. This plate hassimilar contouring to the shorter version of this plate, with a radiuson the bottom and a fishtail curve with a longer, and shallower curvewhich defines a curve that bows in a first direction from the armsthrough the second of the second set of locking holes, and the plateincluding the last two locking holes defines a curve in the oppositedirection. Both of these plates are designed for placement on the middleportion of a clavicle and the choice between the two versions depends onthe placement and nature of the fracture involved.

FIGS. 30 through 41 illustrate plates that are intended for use on thesuperior aspect of the clavicle. Again, left versions are shown, withthe right version being mirror images of the left version. These plates410, 410′ have elongate central trunk portions 412, 412′ with twoopposing pairs of arms 420, 420′. Each of the first 413, 413′ and secondarm 414, 414′ of a pair of arms 420, 420′ include a screw hole 435, 435′which defines an axis of the screw (perpendicular to a tangent at thediameter of the screw hole) and the arms have a longitudinal axis whichis a line intersecting the screw axis and the longitudinal axis of thecentral trunk as medial as possible to the arm. The arms spiral or wraparound in the same direction that the central trunk does. The screwholes 435, 435′ are preferably threaded locking holes, which alsoinclude keyways for a drill guide that sets the angle for the lockingscrew. For each arm, the longitudinal axis defines an angle relative tothe longitudinal axis of the central trunk, and the angle is differentfor one arm than for the other arm as is shown for the embodiment shownin FIG. 1. The plates demonstrates a mirror symmetry about thetransverse plane since the two short arms have a corresponding angle,length and shape and the two long arms have a corresponding angle,length and shape.

The central trunk in the two versions shown in FIGS. 30-41, (with theshorter version shown in FIGS. 30-35 and the longer version shown inFIGS. 36-41,) varies by the length and accordingly by the number ofthrough holes in the trunk. In the shorter version, there are twotranslation slots 416 that are aligned along the medial line and areflanked by a first locking screw hole 417 and a last locking screw hole417. This area of the plate also includes curves between the screw holethat allow the plate to be contoured without bending the through holes.The plate had a shallow longitudinal C curve in the direction away fromthe shorter arm side of the plate. The bottom side 427 of the plate alsoincludes a radius to better accommodate the shape of the bone.

The version of the plate shown in FIGS. 36-41 has a longer central trunk412′ which includes four translation slots 416′ aligned along the medialline and flanked by two locking screw holes 417′. Again, the centraltrunk portion of the plate curves gently in the direction of the shorterarms and the bottom 427′ of the plate includes a radius. FIG. 35 showsthe placement of the shorter plate on the inferior spine of a clavicle.

FIGS. 43-47 illustrate a plate for use on the lateral aspect of theclavicle. This plate 510 has an x-shaped profile, with an elongatecentral trunk and a first pair of arms 520 which extend at differentangles and for different lengths from the trunk and further whichinclude a curve on the bottom side so that the arms spiral around thebone and the screws that are placed in screw holes 535 in the armsprovide for multiplanar fixation and do not impinge on each other. Thecentral trunk includes two translation slots 516 and two locking screwholes 517 in the proximal end of the plate (i.e. adjacent to the endwith the pair of arms 520). The other end of the plate includes a pairof arms 530 that differs from the other pairs in that there is a neckedtransition area 531 including screw holes 532 that are aligned with theterminal screw holes 533 in these arms. There is again a shorter arm 540and a longer arm 541, which include threaded locking screw holes andkeyway guide grooves. The plate has a shallow S shape along the medialline with the more proximal of the two translation slots marking thetransition between the lobes of the S. The plate includes a bottomradius. FIG. 47 shows the plate in position on the distal portion of aclavicle.

While in accordance with the patent statutes, the best mode andpreferred embodiment have been set forth, the scope of the invention isnot limited thereto, but rather by the scope of the attached claims.

What is claimed is:
 1. A method of enabling a surgery on the claviclecomprising providing a surgical tray including at least one screw and apre-contoured plate which has an elongate central trunk which has amedial line and either one pair or not more than two pairs of arms of afirst arm and of a second arm that extend from the central trunk, andthe first arm and the second arm spiraling about the medial line towardeach other, the first arm having an ear with at least a first screw holedefining a first screw hole axis perpendicular to a tangent to the topsurface of the first ear, the first ear being attached to the trunk by alinking section having a waist, a first angle and a first length beingdefined by a line from the first arm screw hole axis to the intersectionof that line with a point on the medial line of the trunk, the secondarm having a second ear with at least a second screw hole defining asecond screw hole axis perpendicular to a tangent to the top surface ofthe second ear, the second ear being attached to the trunk by a linkingsection having a waist, a second angle and a second length being definedby a line from the second arm screw hole axis to the intersection ofthat line with the point on the medial line of the trunk, the firstangle and the first length being different from the second angle and thesecond length whereby the first screw hole axis and the second screwhole axis converge toward each other on the inferior side of the platebut do not intersect, and the tray further including a plate benderwhich will bend the linking section of the first arm and the second armwithout deforming the screw hole of the arm, and a drill guide.
 2. Themethod of enabling a surgery on the clavicle as set forth in claim 1,wherein the surgical tray comprises at least two screws, each having ascrew axis and wherein each of the first screw hole and the second screwhole includes one of the screws, and the screw axes of the two screws donot impinge on each other.
 3. The method of enabling a surgery on theclavicle as set forth in claim 1, further comprising at least two screwseach having a length and a diameter and wherein each arm screw holeincludes one of the two screws wherein the length and diameter of thetwo screws are such that the two screws do not impinge on each other. 4.The method of enabling a surgery as set forth in claim 1, wherein thefirst screw hole and the second screw hole include internal threads. 5.The method of enabling a surgery as set forth in claim 4, wherein thewaist of the linking section of the first arm and of the second arm isconfigured to bend relative to the trunk section in response to a forceapplied before or during surgery without deforming the screw hole. 6.The method of enabling surgery as set forth in claim 1, wherein the trayhas a version of a plate which has a single set of arms to form aY-shaped profile and which has a contour that curves longitudinally in afirst direction and then longitudinally in a second, opposite direction.7. The method of enabling surgery as set forth in claim 1, wherein thetray has a version of a plate which has two sets of arms and which formsa segment of a cylinder or of a torroid.
 8. The method of enablingsurgery as set forth in claim 1, wherein the tray has a version of theplate which has a first terminal end with a single pair of arms withonly one screw hole per arm and which defines a radius on the bonefacing surface and second terminal end with a single pair of arms eachhaving two screw holes and which defines a second radius on the bonefacing surface, which is larger than the radius of the first terminalend.
 9. The method of enabling surgery as set forth in claim 1, whichincludes a first version of the plate which has a single set of arms toform a Y-shaped profile and which has a contour that curveslongitudinally in a first direction and then in a second, oppositedirection; a second version of the plate which has two sets of arms andwhich forms a segment of a cylinder or of a torroid; and a third versionof a plate which has a first terminal end with a single pair of armswith only one screw hole per arm and which defines a radius on the bonefacing surface and second terminal end with a single pair of arms eachhaving two screw holes and which defines a second radius on the bonefacing surface, which is larger than the radius of the first terminalend.
 10. An orthopedic plate system comprising at least one screw and anorthopedic clavicle plate having an inferior surface which is capable offacing a clavicle bone surface in use and which is pre-contoured toaccommodate the shape of that bone surface and an oppositely facingconcentric superior surface, the plate having a central trunk portiondefining a longitudinal trunk axis extending between a first end and asecond end and having at least a portion of the inferior surface whichincludes a curve transverse to the longitudinal axis, said plateincluding at the first end a pair of divergent arms which extend so asto form a left arm and a right arm, each arm including an arm screw holewhich defines a central screw hole axis and the arm being joined to thetrunk portion by a link, each arm of the pair having a longitudinal armaxis which extends between the central screw hole axis and thelongitudinal trunk axis defining an angle with respect to thelongitudinal axis of the trunk area and the angle of the left arm beingα and the angle of the right arm being β where α is different than βsuch that the screw axis of the right arm converges toward but does notimpinge on the screw axis of the left arm and wherein the plate has amedial line which describes a C-curve in the lateral plane or in thelongitudinal plane.
 11. The orthopedic plate system as set forth inclaim 10, wherein said at least one screw has a threaded shaft and ahead and wherein the arm screw hole and the screw head have a matinginterface such that the screw can engage the arm screw hole so as toallow a plurality of angular orientations of the screw axis relative tothe screw hole axis.
 12. The orthopedic plate system as set forth inclaim 11, wherein the mating interface between the screw head and thearm screw holes allows for at least 30° of conical orientation of thescrew axis in the screw hole.
 13. The orthopedic plate system as setforth in claim 10, wherein said at least one screw has a threaded shaftand a head and wherein the arm screw hole and the screw head have amating interface such that the screw can engage the arm screw hole so asto cause a locked angular orientation of the screw axis in the arm screwhole.
 14. The orthopedic plate system as set forth in claim 13, whereinthe screw head includes external threads and the arm screw hole includescorresponding internal threads.
 15. The orthopedic plate as set forth inclaim 14, wherein the system further includes a drill guide and the armscrew hole further includes guide ways for the drill guide which set theangle for the drill guide relative to the plate.
 16. The orthopedicplate system as set forth in claim 15, wherein the screw holes arethreaded and the guide ways are radially spaced grooves that forminterruptions in the threads of the screw hole.
 17. The orthopedic platesystem as set forth in claim 15, wherein the guide ways include at leastthree equally spaced grooves wherein the grooves extend the length ofthe screw hole.
 18. The orthopedic plate system as set forth in claim10, wherein the plate includes two pairs of divergent arms and the plateexhibits mirror symmetry about a transverse plane.
 19. A method ofenabling a surgery on the clavicle comprising providing a surgical trayincluding at least two screws and a pre-contoured plate having aninferior side capable of facing a clavicle in use which has an elongatecentral trunk which has a medial line and either one pair or not morethan two pairs of arms of a first arm and of a second arm that extendfrom the central trunk, the first arm having an ear with at least onescrew hole, the first ear being attached to the trunk by a linkingsection having a waist, the second arm having a second ear with at leastone second screw hole the second ear being attached to the trunk by alinking section having a waist, whereby when in use a first screw axisand a second screw axis converge toward each other on the inferior sideof the plate but do not intersect, and the tray further including aplate bender which will bend the linking section of the first arm andthe second arm without deforming the screw hole of the arm.
 20. Themethod of enabling surgery as set forth in claim 19, wherein each armscrew hole includes one of the screws and the two screws do not impingeon each other.
 21. The method of enabling surgery as set forth in claim20, wherein the length and diameter of the two screws are such that thetwo screws do not impinge on each other.
 22. The method of enablingsurgery as set forth in claim 19, wherein the surgical tray furtherincludes a drill guide.
 23. The method of enabling surgery as set forthin claim 19, wherein the arms of a pair of arm are a pair of divergentarms which extend so as to form a left arm and a right arm, each armincluding an arm screw hole which defines a central screw hole axis ,each arm of the pair having a longitudinal arm axis which extendsbetween the central screw hole axis and the medial line of the trunk anddefining an angle with respect to the medial line of the trunk area andthe angle of the left arm being α and the angle of the right arm being βwhere α is different than β such that the screw hole axis of the rightarm converges toward but does not impinge on the screw hole axis of theleft arm.
 24. The method of enabling surgery as set forth in claim 19,wherein the plate further defines a transverse axis and the plate isbilaterally asymmetrical about the transverse axis.
 25. The method ofenabling surgery as set forth in claim 19, including the further step ofcontouring the first or the second arm using the plate bender.
 26. Themethod of enabling surgery as set forth in claim 19, wherein the platefurther defines a transverse axis and wherein the plate has mirrorsymmetry about the transverse axis.
 27. The method of enabling surgeryas set forth in claim 19, wherein the plate has only one set of arms andan outline that forms a Y-shape.
 28. The method of enabling surgery asset forth in claim 19, wherein the plate has only two sets of terminalarms which are at either end of the elongate central trunk.
 29. Themethod of enabling surgery as set forth in claim 19, wherein the platehas an outline that forms an X-shape.
 30. The method of enabling surgeryas set forth in claim 19, wherein the threaded locking screw holes of aset of arms are placed a radially equal distance from the medial line ofthe elongate central trunk.
 31. The method of enabling a surgery as setforth in claim 19, wherein the elongate central trunk plate has aninferior surface defining a curve transverse to the medial line.
 32. Anorthopedic plate system comprising at least one screw and an orthopedicplate having an inferior surface which is capable of facing a bonesurface in use and an oppositely facing superior surface, the platehaving a central trunk portion defining a longitudinal trunk axisextending between a first end and a second end, said plate including atthe first end a pair of divergent arms which extend so as to form a leftarm and a right arm, each arm including an arm screw hole which definesa central screw hole axis and the arm being joined to the trunk portionby a link, each arm of the pair having a longitudinal arm axis whichextends between the central screw hole axis and the longitudinal trunkaxis defining an angle with respect to the longitudinal axis of thetrunk area and the angle of the left arm being α and the angle of theright arm being β where α is different than β such that the screw holeaxis of the right arm converges toward but does not impinge on the screwhole axis of the left arm and the system further includes a drill guideand the arm screw holes further includes guide ways for the drill guidewhich set the angle for the drill guide relative to the plate.
 33. Theorthopedic plate system as set forth in claim 32, comprising at leasttwo screws which are locking screws, each having a screw axis, andwherein each arm screw hole includes one of the screws.
 34. Theorthopedic plate system as set forth in claim 32, wherein the guide waysare key ways.
 35. The orthopedic plate system as set forth in claim 33,wherein the key ways set the angle for the drill guide.
 36. Theorthopedic plate system as set forth in claim 33, wherein the screwholes are threaded and the guide ways are radially spaced grooves thatform interruptions in the threads of the screw hole.
 37. The orthopedicplate system as set forth in claim 33, wherein the guide ways include atleast three equally spaced grooves wherein the grooves extend the lengthof the screw hole.
 38. The orthopedic plate system as set forth in claim36, wherein the guide ways include three equally spaced grooves whereinthe grooves extend the length of the screw hole.
 39. The orthopedicplate system as set forth in claim 32, wherein the pair of divergentarms extend so as to form a left arm and a right arm.
 40. The orthopedicplate system as set forth in claim 32, wherein the plate further definesa transverse axis and the plate is bilaterally asymmetrical about thetransverse axis.
 41. The orthopedic plate system as set forth in claim32, further comprising a plate bender.
 42. The orthopedic plate systemas set forth in claim 32, wherein the plate further defines a transverseaxis and wherein the plate has mirror symmetry about the transverseaxis.
 43. The orthopedic plate system as set forth in claim 32, whereinthe plate has only one set of divergent arms and an outline that forms aY-shape.
 44. The orthopedic plate system as set forth in claim 32,wherein the plate has only two sets of divergent arms which are ateither end of the central trunk portion.
 45. The orthopedic plate systemas set forth in claim 32, wherein the plate has an outline that forms anX-shape.
 46. The orthopedic plate system as set forth in claim 32,wherein the locking screw holes of a set of arms are placed a radiallyequal distance from the longitudinal axis of the central trunk portion.47. The orthopedic plate system as set forth in claim 32, wherein thecentral trunk portion of the plate has an inferior surface defining acurve transverse to the longitudinal trunk axis.
 48. The orthopedicplate system as set forth in claim 47, wherein the longitudinal trunkaxis of the central trunk portion has a curve along the length of thelongitudinal trunk axis.